Raloxifene Teva

Authorised

This medicine is authorised for use in the European Union

raloxifene

Overview

This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva.

What is Raloxifene Teva?

Raloxifene Teva is a medicine that contains the active substance raloxifene hydrochloride. It is available as tablets (60 mg).

Raloxifene Teva is a ‘generic medicine’. This means that Raloxifene Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Evista.

What is Raloxifene Teva used for?

Raloxifene Teva is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. Raloxifene Teva has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.

The medicine can only be obtained with a prescription.

How is Raloxifene Teva used?

The recommended dose of Raloxifene Teva is one tablet taken once a day. Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Raloxifene Teva is intended for long-term use.

How does Raloxifene Teva work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break (fracture). Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.

The active substance in Raloxifene Teva, raloxifene, is a selective oestrogen receptor modulator (SERM). Raloxifene acts as an ‘agonist’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.

How has Raloxifene Teva been studied?

Because Raloxifene Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Evista. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Raloxifene Teva?

Because Raloxifene Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Raloxifene Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista. Therefore, the CHMP’s view was that, as for Evista, the benefit outweighs the identified risk. The Committee recommended that Raloxifene Teva be given marketing authorisation.

Other information about Raloxifene Teva

The European Commission granted a marketing authorisation valid throughout the EU for Raloxifene Teva on 29 April 2010.

For more information about treatment with Raloxifene Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Raloxifene Teva : EPAR - Summary for the public

Product information

Raloxifene Teva : EPAR - Product Information

Latest procedure affecting product information: N/0029

08/09/2021

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Raloxifene Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Raloxifene Teva
• Active substance:
  raloxifene hydrochloride
• International non-proprietary name (INN) or common name:
  raloxifene
• Therapeutic area (MeSH):
  Osteoporosis, Postmenopausal
• Anatomical therapeutic chemical (ATC) code:
  G03XC01

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Authorisation details

• EMA product number:
  EMEA/H/C/001075
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Opinion adopted:
  18/02/2010
• Marketing authorisation issued:
  29/04/2010
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Raloxifene Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Raloxifene Teva : EPAR - Public assessment report

Committee for Medicinal Products for Human Use positive summary of opinion for Raloxifene Teva

AdoptedReference Number: EMA/CHMP/74631/2010